Status:
UNKNOWN
Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Lymphoma, Non-Hodgkin
Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen ...
Detailed Description
This is a phase II trial investigating tailoring first-line therapy for advanced stage diffuse large B-cell NHL (DLBCL) based on a mid-treatment 18F-FDG- positron-emission tomography (PET) scan result...
Eligibility Criteria
Inclusion
- 18 years of age or older
- newly diagnosed histologically proven CD-20 positive diffuse large B- cell lymphoma by tissue biopsy, listed under peripheral B-cell neoplasm according to the WHO/REAL classification (diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, T-cell rich B-cell lymphoma, intravascular large B-cell lymphoma)
- Advanced stage disease defined as - patients with stage III or stage IV disease; or patients with stage I or stage II disease with one of the following additional criteria: B-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass =\> 10 cm)
- Previously untreated or treated with up to 3 cycles of standard dose 3- weekly R-CHOP chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of R-CHOP chemotherapy)
- ECOG Performance Status 0,1 or 2 at time of enrollment
- No evidence of progressive disease while on R-CHOP chemotherapy
- The patient must sign the consent form prior to registration
Exclusion
- Patients with a history of any other lymphoproliferative disorder, including prior history of indolent NHL
- Patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix
- Known HIV infection
- Known hepatitis B virus infection
- Pregnancy or lactation. Men and women of childbearing age must be using adequate contraception.
- Significant renal insufficiency (serum creatinine \> 200 mmol/L), unless due to lymphoma
- Significant hepatic insufficiency (serum total bilirubin \> 30 mmol/L), unless due to lymphoma
- Cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). If history of cardiac disease, ejection fraction must be within normal limits for age.
- Neurologic contraindication to vincristine (e.g. peripheral neuropathy)
- Absolute neutrophil count \<1.5 x 109/L (unless due to bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
- Platelet count \< 100 x 109/L (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy)
- Evidence of active systemic infection
- Any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00324467
Start Date
August 1 2006
End Date
December 1 2021
Last Update
July 22 2021
Active Locations (1)
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1
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6